InfertilityPhase 2NCT00406874
Effect of Omega 3 Fats on Sperm Quality and Sexual Function
A Phase 2 study testing omega 3 fats and folic acid in people with Infertility, run by Reproductive Partners Medical Group at 1 site in United States.
Trial summary
This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic… Read more about this study
- Who is it for?
- Ages 35 to 55 years, men only
- Conditions the study is for
- Infertility
- What is being tested?
- omega 3 fats and folic acid
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- infertile men
- age 35 to 55
- expressing difficulty timing relations to their partner's ovulation
Who cannot join
- hypertension, heart disease or other systemic diseases
- fatty fish intake more than twice per week
- marked semen abnormalities (less than 10 million sperm per ml, less than 20 % A plus B motility, more than 1 million WBC per HPF)
- use of anticoagulants
- must be willing to not take PDE 5 inhibitors during the study
- use of other supplements is prohibited during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Partners medical Group
Redondo Beach, California, 90277
About this study
Official title: Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55
This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.
Read the detailed description
Infertile men commonly have difficulty timing sexual relations around the time of ovulation. There is a high incidence of abnormal sperm morphology in infertile men. Omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. Omega 3 fats are also important in the structure and function of cell membranes. There is a high incidence of deficient intake of omega 3 fats and folic acid in the U.S. population. Both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements.
Comparison: Omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. They will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. In men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo on their sexual function.
- Conditions
- Infertility
- Being tested
- omega 3 fats, folic acid
- Keywords
- infertility, semen quality, sexual function, blood pressure, omega 3 fats, folic acid
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega 3 fatsDrug
1,000 mg daily
folic acidDrug
800 micrograms daily
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionaires regarding sexual function
Measured: every 30 days
Semen analysis
Measured: every 30 days
Secondary outcomes (2)
blood pressure
Measured: every 30 days
serum nitrate levels
Measured: every 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: reports indicating that increased folic acid intake may increase colin cancer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Partners Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R. Meldrum, M.D., Reproductive Partners Medical Group
- Investigators
- David R Meldrum, M.D., Principal investigator, Reproductive Partners Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406874
- Sponsor's protocol ID
- RPMG-1
- Status last verified
- Jun 2013
- First submitted
- 30 Nov 2006
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Omega 3 Fats on Sperm Quality and Sexual Function in Infertile Men Age 35-55
- ClinicalTrials.gov ID
- NCT00406874
- Acronym / sponsor ID
- RPMG-1
- Conditions
- Infertility
- Keywords
- infertility, semen quality, sexual function, blood pressure, omega 3 fats, folic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: reports indicating that increased folic acid intake may increase colin cancer
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Reproductive Partners Medical GroupUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.
Detailed description
Infertile men commonly have difficulty timing sexual relations around the time of ovulation. There is a high incidence of abnormal sperm morphology in infertile men. Omega 3 fats are known to increase the production of nitric oxide, which is the mediator of the male response, and folic acid is an important cofactor in the production of nitric oxide. Omega 3 fats are also important in the structure and function of cell membranes. There is a high incidence of deficient intake of omega 3 fats and folic acid in the U.S. population. Both folic acid and omega 3 fats are available as nutritional supplements and the doses used in this study are doses commonly recommended as nutritional supplements.
Comparison: Omega 3 fats plus folic acid will be compared with placebo plus folic acid in men age 35 to 55 attempting pregnancy with normal or mildly impaired semen quality. They will fill out dietary questionaires, questionaires regarding sexual function, and will have measurements of serum nitrates, blood pressure, and semen quality before and during use of these nutritional supplements. In men continuing on both omega 3 fats and folic acid, we will compare the effects of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo on their sexual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertile men
- age 35 to 55
- expressing difficulty timing relations to their partner's ovulation
Key exclusion criteria (6 listed)
- hypertension, heart disease or other systemic diseases
- fatty fish intake more than twice per week
- marked semen abnormalities (less than 10 million sperm per ml, less than 20 % A plus B motility, more than 1 million WBC per HPF)
- use of anticoagulants
- must be willing to not take PDE 5 inhibitors during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega 3 fats1,000 mg daily | Drug | – |
| folic acid800 micrograms daily | Drug | – |
Primary outcome
Questionaires regarding sexual function
Time frame: every 30 days
Semen analysis
Time frame: every 30 days
2 secondary outcomes
blood pressure
Time frame: every 30 days
serum nitrate levels
Time frame: every 30 days
Results and safety
The study was stopped early (reason given: reports indicating that increased folic acid intake may increase colin cancer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Meldrum, M.D. principal investigator
Reproductive Partners Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing omega 3 fats and folic acid in people with Infertility, run by Reproductive Partners Medical Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: reports indicating that increased folic acid intake may increase colin cancer). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionaires regarding sexual function (time frame: every 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2013.